(57 days)
The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The Evolution® RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. In use, the coaxial sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9. 11. and 13 French diameters) is designed to rotate in either a uni-rotational or bi-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 40.6 centimeters.
The Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. The outer sheath has winged control tabs located at its proximal (handle) end. The sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9 and 11 French diameters) is designed to rotate in in either a uni-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The devices have a working length of 13.6 centimeters.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the medical device:
The provided document describes physical and mechanical performance testing for the Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set. It does not present a clinical study involving human patients or AI assistance. The "acceptance criteria" and "reported device performance" are based on engineering and laboratory tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Fatigue and Binding Testing | Sheaths should not kink, buckle, or fracture, and both the sheaths and the handle should remain functional after 50 cycles of flexing no less than 90° in opposite directions. (Note: Predicate device had 40 cycles, this device required 10 additional cycles). | These predetermined acceptance criteria were met. |
| 2. Handle Cycling Testing | Sheaths should not kink, buckle, or fracture, and both the sheaths and the handle should remain functional after being subjected to rotation via 2000 pulls of the handle trigger while fixed in a curved position to a radius of 3.5 inches. (Corresponds to predicate device K061000). | These predetermined acceptance criteria were met. |
| 3. Buckling Testing | Sheaths should not kink, buckle, or fracture, and remain functional after being subjected to rotation via 2000 pulls of the handle trigger while fixed in a curved position to a radius of 3.5 inches. (Corresponds to predicate device K061000). | These predetermined acceptance criterion was met. |
| 4. Pull Testing/Sheath Pull Assembly Testing | Each joint in the devices should withstand a minimum of 20 pounds of pull force, after being subjected to the previous tests. (Corresponds to predicate device K061000). | These predetermined acceptance criterion was met. |
| 5. Testing of Reciprocating Action | The rotational mechanism should remain functional through 1000 cycles of alternating clockwise and counterclockwise rotation. | These predetermined acceptance criterion was met. |
| 6. Testing of Continuous Clockwise Rotation | The rotational mechanism should remain functional through 1000 cycles of clockwise rotation. | These predetermined acceptance criteria were met. |
| 7. Testing of Continuous Counterclockwise Rotation | The rotational mechanism should remain functional through 1000 cycles of counterclockwise rotation. | These predetermined acceptance criteria were met. |
| 8. Peel Force Testing | The peel-away outer sheath of the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set should require a peel force of less than 8 pounds. | These predetermined acceptance criteria were met. |
| 9. Biocompatibility Testing | Acceptable in vitro and in vivo results per ISO 10993-1:2009 for external communicating devices in contact with circulating blood for a limited duration (≤ 24 hours), including: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Partial Thromboplastin Time, C3a Complement Activation, SC5b-9 Complement Activation, and Pyrogenicity. | Biocompatibility was deemed acceptable. |
| 10. Sterility Testing | Acceptable bioburden levels, endotoxin levels, and ethylene oxide and ethylene chlorohydrin residuals. | Sterility was deemed acceptable. |
Regarding the other requested information:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample sizes (number of units tested) for any of the engineering or laboratory tests.
- The data provenance is from Cook Vascular, Inc. in the U.S.A. The tests are described as prospective laboratory and engineering tests, performed to meet design requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This device clearance is based on mechanical, physical, and biocompatibility testing, not on a diagnostic or interpretive task that would require expert human judgment to establish a "ground truth." Therefore, there were no specific clinical experts establishing ground truth in the context of the tests described. The "experts" would be the engineers and scientists conducting and evaluating the specified tests against predetermined performance criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable here. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple experts evaluate cases and a consensus or tie-breaking mechanism is needed for ground truth. The tests described are objective engineering measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This document is for a medical device (dilator sheath) and does not involve AI or human "readers" evaluating images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone (algorithm-only) performance study was done. This device is a mechanical tool and does not employ an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the engineering and biocompatibility tests was based on predefined objective performance metrics and regulatory standards (e.g., "not kink, buckle, or fracture," "withstand a minimum of 20 pounds of pull force," "functional through 1000 cycles," "peel force of less than 8 pounds," and compliance with ISO 10993-1 for biocompatibility).
8. The sample size for the training set
- This concept is not applicable as this is not an AI/machine learning device. There was no training set.
9. How the ground truth for the training set was established
- This concept is not applicable as there was no training set.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).